A Multi-center, Single-arm Study of BICUN (Edaravone Injection) in Treating Acute Large Area Cerebral Infarction

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-16009275

Enrollment

Unknown

Registered

2016-09-26

Start date

2016-10-31

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Interventions

experiment group:BICUN(Edaravone Injection)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Hospitalized patients aged 18 to 80 years old, either gender; 2. Acute ischemic stroke diagnosed in accordance with all kinds of cerebrovascular disease diagnosis points set by the 4th national cerebrovascular disease conference; 3. Large area cerebral infarction tested with MR and CT brain images (infarction diameter>3cm, and infarction occurring to at least two lobes); 4. Attack time=72h; 5. With specific signals and signs in the nervous system and scores of neurologic impairment: 4=NIHSS=24 6. No serious systemic complications; 7. No bleeding tendency confirmed by CT scan; 8. Informed consents shall be signed by patients or legal representatives authorized by patients.

Exclusion criteria

Exclusion criteria: 1. Intracerebral hemorrhagic diseases detected by CT scan including: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage and subarachnoid hemorrhage; 2. Severe conscious disturbance; 3. Patients with severe primary heart and lung diseases, liver and renal insufficiency or serious secondary infection; 4. Move than two medicines of the following neuroprotective agents such as gangliosides, citicoline, piracetam, butylphthalide and urinary kallidinogenase have been given to the patients;; 5.Patients with poor compliance due to severe mental diseases or dementia; 6. Allergic constitution and allergic history to diverse medication; 7. Female patients during their gestation period or lactation period; 8. Patients with other brain organic diseases like brain tumors; 9. Patients with the necessity of receiving surgery; 10. Patients who have already been involved in the other clinical trails; 11. Patients who are not considered to be suitable for the trail by researchers.

Design outcomes

Primary

Measure	Time frame
NIHSS scores;	—

Secondary

Measure	Time frame
mRS scores;Brian CT or MRI images;	—

Countries

China

Contacts

Public ContactQin Chao

The First Affiliated Hospital of Guangxi Medical University

404155788@qq.com+86 13517666639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026